Agreement seeks to leverage point-of-need molecular testing platform for early detection of H5 and seasonal influenza viruses.
November 19, 2024
Alveo Technologies Inc., a leader in molecular sensing and diagnostics, announced that it signed an agreement issued by the U.S. Centers for Disease Control & Prevention on a competitive basis to develop a rapid, molecular, point-of-need diagnostic to detect and differentiate between influenza A + B and A/H5 in humans.
In June, CDC issued an open call for innovative solutions to meet its diagnostic test development needs for avian influenza. The virus has been confirmed in birds, cattle, poultry and people in the U.S., heightening the urgency to support advanced preparedness in the event that human-to-human transmission occurs.
As of Nov. 18, 2024, bird flu has affected more than 108 million poultry in 48 states and 549 dairy herds in 15 states, along with 52 confirmed cases in humans in several states, CDC reported on its H5 Bird Flu: Current Situation webpage.
According to CDC, all recent human cases have occurred in workers on affected farms. “All available data so far suggest sporadic instances of animal-to-human spread. These farm workers all described mild symptoms,” the agency noted, adding that some some mild upper respiratory symptoms. None of the workers were hospitalized.”
In its open call to industry that requested innovative solutions from diagnostic technology companies, CDC reported that “currently, the only public health laboratories in the U.S. equipped to test for this virus are CDC and state and jurisdictional public health laboratories with access to the CDC A(H5) assay. This poses a significant problem as these laboratories may not have the capacity to handle a large number of cases in the event of an H5 epidemic or pandemic. This could result in delays in diagnosing and treating individuals, leading to the further spread of the virus.”
Alveo noted that has developed a portable, easy-to-use molecular detection platform that utilizes isothermal nucleic acid amplification technology and provides fast and qualitative results at the point of need. As a multiplexed platform, the device can detect and differentiate between influenza A, B and A/H5 from a single sample. Additionally, the platform can automatically deliver accurate, real-time results via a secure, cloud-based portal for analysis and reporting.
As a result, Alveo said its solution can facilitate early detection and intervention, enhance public health surveillance and improve the overall response to seasonal influenza and potential avian influenza A/H5 outbreaks. By decentralizing testing capabilities, Alveo will increase access to critical diagnostics, reduce the burden on centralized laboratories and bolster pandemic preparedness and response efforts.
The agreement with CDC to develop avian influenza tests is just part of Alveo’s broad strategy to develop diagnostics to manage global health, food security and supply chain resiliency, according to the announcement. Alveo will begin shipping a molecular test in December for all relevant subtypes of avian influenza (Type A, subtypes H5, H7, H9) in poultry. The CDC agreement and development goals support a natural expansion of Alveo’s product line, given its synergies with assays already developed.
“It is gratifying to be selected and enter this agreement to accelerate the development of our point-of-need diagnostic solutions for H5,” Alveo chief executive officer Shaun Holt said. “We are proud to work with CDC to be a part of a national preparedness effort by enabling timely detection and response where it matters most – at the front lines of care.”
Based in Alameda, Calif., Alveo makes molecular detection and diagnostics universally accessible on the farm, in the field, in the clinic or in the manufacturing plant to help prevent or significantly limit the destructive impact of viruses, fungi, bacteria and other pathogens by detecting earlier at the point of need.
The company’s portable, multiplex-capable diagnostic platform employs IntelliSense, its patented method of direct electrical sensing of nucleic acid amplification, to provide affordable, rapid and accurate results.
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